MedWarn.org
  • Alerts
  • Drugs
    • ADHD Medications
    • Allergy Treatments
    • Antidepressants
    • Antipsychotics
    • Antibiotics
    • Antiseizure
    • Arthritis
    • Cancer Treatments
    • Cardiovascular
    • Diabetes Treatments
    • Dietary Supplements/Weight Loss
    • Erectile Dysfunction
    • Gastrointestinal
    • Hormone Therapy
    • Oral Contraception
    • Pain Relief
    • Respiratory
    • Skin Conditions
    • Sleep
  • Vaccines/Biologics
    • Blood Products
    • Genetic Testing
    • Tissues
    • Vaccines
  • Devices
    • 3D Printed
    • Autoinjectors
    • Brain Devices
    • Breast Implants
    • Cardiac Devices
    • Contraceptive Devices
    • Cyber Security
    • Home Health Devices
    • Hip Implants
    • Infusion Pumps
    • Respiratory Systems
    • Stents
    • Surgical Devices
    • Transvaginal Mesh
  • Tobacco
  • Resources
    • Product Safety and the FDA
    • Product Recalls
    • Product Liability Lawsuits
    • Questions For A Lawyer
    • Get Help
  • About Us

Alerts, Recalls, and Legal Headlines

Sign-up to receive recall notices, medical news, and litigation updates.

SIGN-UP

Safety Information: Stryker Wingspan Stent System

1/31/2013

0 Comments

 
After reviewing updated safety and risk information, FDA changed the indications for use and labeling for Stryker’s Wingspan Stent System (“Wingspan”) by limiting approval to a very specific group of patients who are at serious risk of lifte-threatening stroke and have limited alternative treatment options.   The Wingspan should not be used for:
  •  the treatment of stroke with an onset of symptoms within seven days or less, or
  •  for treatment or for the treatment of transient ischemic attacks (TIAs).  
Wingspan is used to open narrowed arteries in the brains of patients diagnosed with intracranial stenosis who are experiencing repeated strokes. Stenosis, or narrowing of the intracranial arteries, is a serious condition caused by a buildup of plaque within the arteries, and there are few treatment options available for managing this condition. Patients with intracranial stenosis are at serious risk of life-threatening strokes due to reduced blood flow to the brain from narrowed or blocked arteries. The Wingspan stent is intended to reopen narrowed arteries in certain patients to potentially prevent additional strokes. 
[1] FDA Safety Communication, "Narrowed Indications for Use for the Stryker Wingspan Stent System" (January 31, 2013).



0 Comments

Your comment will be posted after it is approved.


Leave a Reply.

    Archives

    May 2014
    April 2014
    March 2014
    February 2014
    January 2014
    December 2013
    November 2013
    September 2013
    July 2013
    June 2013
    May 2013
    March 2013
    January 2013
    July 2012
    June 2012
    March 2012
    February 2012
    August 2011
    December 2010
    August 2010
    February 2009
    July 2008

    RSS Feed

    Categories

    All
    3D Printing
    3D Printing
    Acid Reducers
    Acne Treatments
    ADHD
    Allergies
    Antibiotics
    Antidepressants
    Anti-Epilepsy
    Antipsychotics
    Antiviral
    Arthritis
    Aspirin
    Asthma
    Autism
    Birth Control
    Birth Defects
    Blood Products
    Bone
    Brain
    Cancer
    COPD
    Cyber Crime
    Diabetes
    Dietary Supplements
    Dna-testing
    E-cigarettes
    Electronic Health Records
    Eliquis
    Epilepsy
    FDA/Approvals
    FDA Recalls
    FDA/Recalls
    FDA Warnings
    FDA Warnings
    Hearing-devices
    Hearing Loss
    Heart
    Hemophilia
    Hip Implants
    Hormone
    HPV
    Infants
    Infusion Pump
    Invokana
    Legal News
    Migraines
    Mirena
    Monitors
    Multiple Sclerosis
    Pain Relief
    Research
    Resuscitation
    Risperdal
    Sleep
    Stents
    Stroke
    Surgical Device
    Surgical Device
    Topamax
    Transvaginal Mesh
    Vaccine
    Weight Control
    Weight Control

    RSS Feed



    120x600
Need help finding a medical or legal professional?  Email us at info@medwarn.org

Home
About Us
Get Alerts

Privacy Policy
Terms of Use
Get Help
© 2014 MedWarn LLC
Photo used under Creative Commons from Official U.S. Navy Imagery